AVENIO ctDNA Surveillance Kit V2

RUO For Research Use Only. Not for use in diagnostic procedures.

Optimized tumor burden monitoring in lung and colorectal cancer research

The AVENIO ctDNA Surveillance Kit is a next-generation sequencing (NGS) liquid biopsy research use only assay that’s specially designed and optimized for longitudinal tumor burden monitoring in lung cancer and colorectal cancer (CRC) research. The Surveillance panel contains 197 genes, including those in the US National Comprehensive Cancer Network (NCCN) Guidelines.1

Benefits at a glance

Benefits at a glance

AVENIO ctDNA Surveillance Kit V2 analytical performance3

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AVENIO ctDNA Surveillance Kit V2 analytical performance3

Mutation class

SNVs

Indels

Fusions

CNVs**

Mutant allele frequency/copy number 0.5%* 1.0%* 1.0%

Sample dependent

 

Sensitivity and PPV Sensitivity PPV Sensitivity PPV Sensitivity PPV
>99% >95% >99% >99% >99% >99%
*The reported sensitivity and PPV is for 50 ng DNA input at the stated AF%. The kit has the ability to report variants down to 0.1% AF (with lower sensitivity), and can make libraries with as low as 10 ng.
**The kit reports ERBB2, EGFR, and MET CNVs. Performance is dependent on various factors, including sample type, input DNA amount, percent tumor content, and the individual tumor's genomic copy number. Our technical study detected CNVs at dPCR-verified copy numbers, using a commercially available reference sample (50ng). CNV specificity was high (PPV >99%). ERBB2 detected at 4.5 copies, MET detected at 4.5 copies.
Performance samples: Seraseq ctDNA Complete Mutation Mixes (SeraCare), healthy donor cfDNA.
Sensitivity and Positive Predictive Value (PPV) metrics based on observed product performance. Sensitivity and PPV performance reported per variant. Sensitivity was determined using commercially available reference samples containing verified mutations at the stated allele frequencies. SNV performance data based on hotspot calls. The AVENIO ctDNA Analysis Kit V2 can achieve >99.99% per base specificity across each of the panels. Stated performance requires at least 40 million reads per sample for all AVENIO ctDNA Panels V2. Sequencing performed on an Illumina NextSeq 500/550/550Dx (Research Use Only mode) instrument.

AVENIO ctDNA Surveillance Kit V2 specifications

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AVENIO ctDNA Surveillance Kit V2 specifications

Product specifications 

Value

Panel size

198 kb

Sample size

4 ml of plasma

cfDNA input

10-50 ng

Reactions per kit

16

Turn-around time

5 days from extraction to results

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Overview

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Key product features

NCCN guideline genes: The assay includes genes in the U.S. National Comprehensive Cancer Network (NCCN) Guidelines.1

All mutation classes: All four mutation classes (SNVs, indels, fusions, and CNVs) are included in one assay.

Comprehensive package: The assay is inclusive of reagents, bioinformatics, and software.

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AVENIO assays are for Research Use Only. Not for use in diagnostic procedures.

References

  1. National Comprehensive Cancer Network [Internet; cited 2025 Nov 20]. Available from: https://www.nccn.org/
  2. Newman AM, Bratman SV, To J, et al. An ultrasensitive method for quantitating circulating tumor DNA with broad patient coverage. Nature Med. 2014;20(5):548–554 doi:10.1038/nm.3519. Available from: https://www.nature.com/articles/nm.3519
  3. F. Hoffmann-La Roche Ltd. Data on file.